HRD CANCER FULL

The FDA also approved the Myriad mењњhoice CDx test for determination of tumor HRD status to select patients for niraparib.

HRD CANCER FULL

View full prescribing information for ZEJULA. Patients should be selected for therapy based on an FDA-approved companion diagnostic for niraparib. The recommended niraparib dose is 300 mg taken once daily with or without food. The most common adverse reactions ( >5%) resulting in dose reduction or interruption were thrombocytopenia (40%), anemia (21%), neutropenia (11%), nausea (13%), vomiting (11%), fatigue (9%), and abdominal pain (5%). Estimated median DOR was 8.3 months (95% CI: 6.5, not estimable).ДЇor patients with t BRCAm ovarian cancer, ORR was 39% (7/18 95% CI: 17, 64) in patients with platinum-sensitive disease, 29% (6/21 95% CI: 11, 52) in those with platinum-resistant disease, and 19% (3/16 95% CI: 4, 46) in patients with platinum-refractory disease.ДЄdverse reactions led to dose reduction or interruption in 73% of patients receiving niraparib in QUADRA. In the 98 patients in the HRD-positive cohort, ORR was 24% (95% CI: 16, 34). The primary efficacy outcome measures were objective response rate (ORR) and duration of response (DOR), as assessed by the investigator using RECIST 1.1. All patients received 300 mg of niraparib once daily until disease progression or unacceptable toxicity HRD-positive status was determined using the Myriad mењњhoice CDx as either tumor BRCA mutated (t BRCAm) (n=63) and/or a genomic instability score (GIS) в‰Ґ 42 (n=35). Patients without BRCA mutations must have progressed at least six months after the last dose of platinum-based therapy. Patients with prior exposure to PARP inhibitors were excluded.

Patients were treated with three or more prior lines of chemotherapy. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.Д®fficacy was investigated in 98 patients with advanced ovarian cancer with HRD-positive tumors in the single-arm QUADRA (NCT02354586) trial. On October 23, 2019,the Food and Drug Administration approved niraparib (ZEJULA, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

Hrd cancer